ANATEL 00202-15-05304

NG3

Applicant: Boston Scientific do Brasil Ltda.   Date: 2026-07-10

Device Details - en | pt-br

Approval Number00202-15-05304
Homologation Number002021505304
ModelNG3
Product TypeMedical Implant Communication System (MICS)
Product CategoryCategory 2
ApplicantBoston Scientific do Brasil Ltda.
Applicant CNPJ01513946000114
ManufacturerCardiac Pacemarker Incorporated
Manufacturer CountryUnited States of America
Conformity CertificateNCC 29132/26
Certificate Issued2026-02-19
Certificate Valid Until2027-01-19
Certificate StatusSubmission completed
Requirement StatusHomologation issued
Homologation Date2026-07-10
IC AntennaN
IC ActiveS
CodUITUSA
CodISOUSA
Source Presenceseen
Last Seen2026-09-16

Models Under This ANATEL Homologation

ApprovalDateModelStatusProduct TypeManufacturerApplicant
00202-15-053042026-07-10NG3Homologation issuedMedical Implant Communication System (MICS)Cardiac Pacemarker IncorporatedBoston Scientific do Brasil Ltda.
00202-15-053042026-07-10NG4Homologation issuedMedical Implant Communication System (MICS)Cardiac Pacemarker IncorporatedBoston Scientific do Brasil Ltda.

ANATEL Documents

DocumentTypeDate
Manual Tachy CRT-D PTM Atualizado_Res 662Manual2017-01-20
Manual Tachy MRI Atualizado_Res 662Manual2017-01-20
Manual Tachy ICD Atualizado_Res 662Manual2017-01-20
Foto Selo Anatel Atualizado_Res 662Selo Anatel2017-01-20
Certificado de Conformidade Técnica NCC 11635/16_M1_Re1Certificado de Conformidade2017-01-20
Fotos externas M1Fotos Externas2016-11-01
Certificado de Conformidade Técnica NCC 11635/15_M1Certificado de Conformidade2016-11-01
Foto Selo ANATEL_REVSelo Anatel2015-01-21
ManualManual2015-01-20
ManualManual2015-01-20
ManualManual2015-01-20
Selo ANATELSelo Anatel2015-01-20
Fotos externasFotos Externas2015-01-20
Certificado de Conformidade NCC_11635_15_BostonCertificado de Conformidade2015-01-20